Every year hundreds of millions of individuals worldwide suffer from serious lower gastrointestinal (GI) diseases and disorders (e.g., fecal anal incontinence/laxity, hemorrhoids, colitis) requiring intervention. The technology incorporated in the design of gastrointestinal devices has seen little to no developmental progress in recent years. Indeed, biopsy forceps, polypectomy snares and fine aspiration needles have seen so little change that they are becoming commodities. Though these conventional devices remain limited in their efficacy, the incidence of these disease states continues to increase.
Fecal incontinence, the involuntary loss of stool or air per anus, is a common clinical problem, typically resulting from sphincter injury (most often in women during labor). According to the National Health and Nutrition Examination Survey (NHANES) the prevalence of fecal incontinence in U.S. adults is approximately 10%. Nearly 18 million U.S. adults (about 1 in 12) have fecal incontinence. Further, the prevalence approaches nearly 50% of nursing home residents, with no effective non-surgical treatment. Often, fecal incontinence is a primary condition for motivating caregivers to move the elderly into nursing home facilities from private residences. Social embarrassment, fear about the cause, or even a misconception that incontinence is part of the normal aging process may prevent patients from revealing these symptoms to their healthcare providers. The severity of the condition often mandates continuous protection from soiling, and robs patients of their quality of life and independence.
Over $400 million per year is spent on adult diapers and protective clothing in the U.S. alone. These symptoms may persist for years before a patient vocalizes complaints and obtains relief. Adding to this is the financial burden to the individual and society. The healthcare cost of incontinence among U.S. adults in 2000 was estimated at $20 billion. Over 50% of these costs are attributed to resources necessary to manage the patients' condition including nursing home and assisted-living caregiver salaries, and absorbent pads and diapers. The 2010 national annual average cost for fecal incontinence care was $4,000 per person. Treatments for fecal incontinence include fiber supplements, biofeedback to train the sphincter, exercises to tighten the sphincter, and surgery. Unfortunately, these available treatments outside of invasive surgery are lengthy and often ineffective. Inadequate repair or poor healing of obstetric perineal injuries may present as anal incontinence within days to weeks of delivery. In fact, some authors have reported an incidence of anal incontinence after third- or fourth-degree laceration as high as 40-60% of women. Various fillers, such as collagen/silicone, may be injected to treat such laxity by increasing the pressure resistance of the internal sphincter.
Many other GI disorders have a major impact on health. For example, hemorrhoids—inflamed and swollen veins in the anus or lower rectum—are extremely common, accounting for some 50 million procedures performed worldwide. The two most common office-based procedures used to treat symptomatic hemorrhoids are rubber band ligation (RBL) and sclerotherapy (SCL). RBL involves stretching an elastomeric band about a target vein such that it constricts and substantially halts blood flow through the vein, causing it to shrivel over time, thus reducing and eliminating the hemorrhoid. SCL involves injecting a sclerosing solution into a target vein, which causes the vein to shrivel over time, again reducing and eliminating the hemorrhoid.